MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION REVACLEAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 114745L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported the patient experienced a reaction to a revaclear 300 set.During hemodialysis therapy, the patient had a reaction with generalized itching, swelling of the skin around the eyes, and a headache.The patient was suggested to treat the symptoms with benadryl (diphenhydramine hci) and tylenol (acetaminophen) for the headache prior to hemodialysis therapy.Also suggested to apply a cold washcloth to their eyes for swelling.No further information was available at the time of this report.

• Brand Name: REVACLEAR
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - OPELIKA; 1101 jeter ave; opelika AL 36801
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17883148
• MDR Text Key: 325063484
• Report Number: 3006552611-2023-00049
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K130039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114745L
• Device Lot Number: C623306506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/05/2023
• Date Device Manufactured: 03/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NI.
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 75 KG